In finalizing Maine’s ban on pharmaceutical manufacturer gifts to health care practitioners, the Maine Board of Pharmacy responded to the Insights Association that it should not restrict respondent incentives for participation in bona fide marketing research.
The new regulations were provisionally adopted on June 6, 2019, but were not approved until a Board of Pharmacy meeting on May 7, 2020 and became effective on June 6, 2020.
Sec. 1. 32 MRSA §13759 within the Maine Pharmacy Act prohibits prescription drug manufacturers and wholesalers (or their agents) from offering or giving a “cash gift in any amount” or a “gift for which reciprocity is expected or implied” to a health care practitioner. Although the Insights Association, the leading nonprofit trade association for the marketing research and data analytics industry, explained to the sponsor of the law and committee leaders in the legislature why respondent incentives are not gifts and are not part of influencing practitioners’ decision making, and offered amendments like the ones we successfully won in California in 2017, Maine rushed the state's 20017 law with no clear protections for marketing research incentives.
IA had commented to the Board of Pharmacy that the “2017 law has inadvertently banned respondent incentives for practitioners who participate in pharmaceutical marketing research studies, even though such incentives are usually offered by independent marketing research companies and the sponsoring manufacturers are not aware of which practitioners participated.”
In releasing the final regulations, the Maine Board of Pharmacy (on page 8) stated that it “understands the spirit of these comment” about the difference between a gift and a service arrangement compensated at fair market value. “The Board does not believe the law prohibits payment to a practitioner for services rendered and would not be a matter subject to Board action. Addressing or proposing something other than a gift is not within the purview of the Board.”
Maine has induced a legal compliance yo-yo effect for the marketing research industry for more than a decade. Maine used to be a no-go state for pharma MR with doctors, thanks to a Physician Payments Sunshine Act-style law requiring the reporting of expenses for marketing to Maine physicians (which the regulator interpreted to include marketing research). Pharmaceutical companies treated that law as a de facto ban. With our endorsement, the legislature repealed the law in 2011. Then, the legislature passed the most recent law, L.D. 911, in 2017, yo-yoing back to another presumed ban.
Now, after another three years of a presumed ban, bona fide pharmaceutical marketing research with Maine-licensed health care practitioners should be back in business.
The regulations (Chapter 12, Licensure of Manufacturers and Wholesalers and “7. Exception to Prohibition Against Gifts to Practitioners”) primarily clarify definitions relating to the law:
- Per the statute, a “practitioner” is “an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice.” However, the Board of Pharmacy made sure to clarify in the final regulations that the term “does not include pharmacists” and only “applies to Maine licensed practitioners.”
- Per the regulations, “modest meals and refreshments” means “food and beverage of minimal value provided to a practitioner in connection with a meeting or presentation about the benefits, risks, and appropriate uses of prescription drugs or medical devices, disease states, or other scientific information as long as the meeting or presentation occurs in a venue and manner conducive to informational communication. Such food and beverage must be of the type and quantity typically provided for conference attendees at the venue where the meeting or presentation occurs.”
- The final version of the regulations also adds: “For purposes of this section, minimal value means the cost of which is similar to that which a practitioner would pay when dining at his or her own expense as judged by local standards where the event is held.”
- The regulations define “reasonable honoraria” as “cash, gratuity and/or a gift given to a practitioner in recognition for the Maine licensed practitioner speaking at a professional or educational conference sponsored by a manufacturer or wholesaler. The aggregate value of all cash and gifts received by a practitioner for a particular speaking engagement may not exceed an annual limit of $500 in retail value.” The term “does not include or apply to: A. The fee for service paid to the practitioner for the presentation, travel or lodging reimbursement, or other expenses incurred; or B. Where the manufacturer or wholesaler sponsoring the event does not participate or have influence over the selection of the practitioner chosen for the speaking engagement or payment for the services rendered by the practitioner.”
- “Reasonable expenses” are “the reasonable and actual expenses for travel, lodging, and meals incurred by a practitioner and that are necessary in order for the practitioner to speak at a professional or educational conference sponsored by a manufacturer or wholesaler.”
The Insights Association provided one last important point for compliance in response to the final regulations from the Maine Board of Pharmacy: marketing researchers should consider avoiding the term “honoraria” to describe respondent incentives provided to health care practitioners, at least with Maine-licensed practitioners. IA and our industry have gone to great lengths to explain to legislators and regulators across the country that these incentives are provided at fair market value in lawful exchange for a service. Again, as the Board of Pharmacy stated, “payment to a practitioner for services rendered” are beyond their purview. Given the Board of Pharmacy’s focus on the potential for “honoraria” in certain circumstances to constitute a prohibited “gift” in the new regulations, it is incumbent upon marketing researchers to not confuse the issue with misapplied terminology.
This information is not intended and should not be construed as or substituted for legal advice. It is provided for informational purposes only. It is advisable to consult with private counsel on the precise scope and interpretation of any laws/regulation/legislation and their impact on your particular business.